PART I: ITEM-BY-ITEM INSTRUCTIONS FOR THE ONLINE … Document Library...California Safe Cosmetics Program – California Department of Public Health Page 1 of 38 . Instructions for

California Safe Cosmetics Program – California Department of Public Health Page 1 of 38

Instructions for the California Safe Cosmetics Program Online Reporting System California Department of Public Health

California Safe Cosmetics Program September 2018

Navigation .......................................................................................................... Page

PART I: ITEM-BY-ITEM INSTRUCTIONS FOR THE ONLINE REPORTING FORMS Special notes on preparing your submissions ..................................................................................... 3

Requesting a user name and password ............................................................................................. 4

Welcome Page ................................................................................................................................ 5

Login Page ...................................................................................................................................... 5

Request Login/Company Information Page ........................................................................................ 6

Cosmetic Firm’s Profile ..................................................................................................................... 6

Cosmetic Firm’s Contact Person’s Information ................................................................................... 7

Submitter’s Information ................................................................................................................... 7

Submitter’s Firm Information ............................................................................................................ 8

Specify User Name and Password ..................................................................................................... 9

Annual Questions ........................................................................................................................... 10

Home Page ................................................................................................................................... 10

Reported Products Page ................................................................................................................. 11

Add New Product ........................................................................................................................... 11

Product Page ................................................................................................................................. 12

Manufacturer – Firm Details Page ................................................................................................... 13

Product Categories Page ................................................................................................................ 14

Product Components Page ............................................................................................................. 15

Base Formulation Chemicals Page ................................................................................................... 16

Base Formulation Chemical Details Page ......................................................................................... 17

Color-Scent-Flavor Combinations Page ............................................................................................ 19

Kits & Collections ........................................................................................................................... 20

Kits ............................................................................................................................................... 20

Collections .................................................................................................................................... 21

CSF Chemicals Page ....................................................................................................................... 21

CSF Chemical Details Page ............................................................................................................. 22

Product Submission Receipt Preview Page ....................................................................................... 24

Electronic Signature Page ............................................................................................................... 24

Thanks! ........................................................................................................................................ 25

California Safe Cosmetics Program Online Reporting System – Reporting Instructions Page 2 of 38

California Safe Cosmetics Program – California Department of Public Health September 2018

Update Company Information ......................................................................................................... 25

Attachment 1: Cosmetic Product Categories .................................................................................... 27 Attachment 2: Definitions ............................................................................................................... 30

PART II: GENERAL INFORMATION ABOUT REPORTING The California Safe Cosmetics Program Reporting System ................................................................ 32

Companies that are required to report ............................................................................................ 32

Cosmetic products that must be reported ........................................................................................ 33

Cosmetic products/ingredients that are not subject to the reporting provisions of the Act .................. 34

System security ............................................................................................................................. 35

Deadline for submitting information to the California Department of Public Health ............................. 35

Trade Secrets ................................................................................................................................ 35

Product Submission Receipts .......................................................................................................... 36

Delete Requests ............................................................................................................................ 37

Discontinued Products ................................................................................................................... 37

Product Reformulations .................................................................................................................. 37

Availability of company/product information .................................................................................... 38



PART I: ITEM-BY-ITEM INSTRUCTIONS FOR THE ONLINE REPORTING FORMS

Special notes on preparing your submissions As not all abbreviations are standard, please do not use abbreviations unless it is part of a specific product label name. Dates should be entered in MM/DD/YYYY format. Cosmetic products should be reported per formulation. For example, a hair styling aid that has the same name on the label, but is sold as a spray and a cream having different formulations, should be reported separately as two different products. However, if there is a change in a product’s name with no change in the formula, the product should be reported under the new product name so that it can be properly identified. The discontinued product should be marked as discontinued (refer to the “Discontinued products” section of this document). If a product is available in multiple colors, scents, or flavors, it can be reported as one product entry, provided they share the same base formulation. The reporting form will indicate where to report ingredient(s) specific to the color, scents, or flavors. For more information on reporting multiple colors, scents, or flavors, refer to the Color-Scent-Flavor Combinations Page of this document All reported information is intended to be made available to the public. However, if the product or product ingredients qualify as trade secret, the information will not be made public. For each field marked as trade secret, you are required to mail supporting documentation to:

California Department of Public Health California Safe Cosmetics Program 850 Marina Bay Parkway Building P, 3rd Floor Richmond, CA 94804

For more information on requesting confidentiality, please refer to the “Trade secrets” section of this document.



Requesting a user name and password To self-assign your unique user name and password, click the “Request new login account” link at the Login screen. This will direct you to the cosmetic firm profile page where you will be asked basic cosmetic firm background information and user name and password assignments.

Consultants or companies reporting on behalf of another company will need a separate user name and password for each company for which they are reporting. For information on how to complete this form and self-assign User Names/Passwords, see the “Request Login/Company Information” section below. If you have forgotten your password, please do not create a new user account; doing so will not link products from your old account with your new account. Instead, contact the California Safe Cosmetics Program (CSCP) at [email protected] to reset your password.

mailto:[email protected]



Welcome Page

To submit your cosmetic company and product information to the California Department of Public Health, click on the lick “Cosmetic firms – Submit information to the CSCP” link. This will direct you to the Login Page.

Login Page If you have already established an account, please enter your user name and password in the appropriate fields. Then hit the “Log In” button to access your account. If you would like to establish an account, please click on the “Request new login account” link. This will direct you to the cosmetic firm profile page where you will be asked to enter information about your company to obtain user name and password assignments.

Note: Consultants or companies reporting on behalf of another company will need a separate user name and password for each company for which they are reporting. If you have forgotten your user name and/or password, please send an email to [email protected] to reset the password to your existing account. In the email, please include your user name (if known), your name and job title, and your company contact information. If you have forgotten your password, please do not create a new user account; doing so will not link products from your old account with your new account. Instead, contact the CSCP at [email protected] to have your password reset.





Request Login/Company Information Page Complete the information below to request an account.

Cosmetic Firm’s Profile • Name of Firm:

Enter the full legal name of your cosmetic firm. • Other Names (DBA):

If applicable, enter any other name(s) your cosmetic firm may be doing business as. • Corporate Name (if applicable):

If applicable, enter corporate name for this cosmetic firm. • FDA CFN/FEI (if applicable):

If applicable, enter the US Food and Drug Administration Central File Number or Federal Establishment ID for this firm.

• Website (URL):

If applicable, enter the Web site address for this cosmetic firm. • Company Type:

Select whether this cosmetic firm is a “Public Company” or “Private Company.” • Business Address Line 1:

Enter the number and street address for this firm. • Business Address Line 2:

If applicable, enter suite, floor, room number, etc. information. • City of Business:

Enter the full city name where this firm is located. • State/Province:

Enter the state or province where this firm is located. • Zip/Postal Code:

Enter the zip code or postal code where this firm is located. • Country:

Enter the country where this firm is located. • How is this firm named on the label of products to be reported? (check all that apply)

Select whether your firm manufactures, packages, and/or distributes cosmetic products to be reported. If you are not a manufacturer, packer, and/or distributor of cosmetic products to be reported, select “Not named on the label of products to be reported.”



Cosmetic Firm’s Contact Person’s Information The Cosmetic Firm’s Contact Person should be the main contact person for this firm. This person may be contacted for verification purposes and/or further information regarding your cosmetic product submission(s). • First Name:

Enter the contact person’s first name. • M.I.:

If applicable, enter the contact person’s middle initial. • Last Name:

Enter the contact person’s last name. • Title:

Enter the contact person’s full job title; for example, Regulatory Affairs Manager. • Email Address:

Enter the contact person’s Email address. • Telephone Number:

Enter the contact person’s telephone number, include applicable country codes, area codes, and phone extension numbers.

• Fax Number:

Enter the contact person’s fax number, include applicable country codes, area codes.

Submitter’s Information The Submitter is the person who will be completing the online submission of cosmetic products for the Cosmetic Firm. If this person is the same as the person indicated in the Cosmetic Firm Contact Person’s Information section, check the “Same as Cosmetic Firm Contact Person” box. • Will the Submitter be the same as Cosmetic Firm Contact Person?

Select “yes” or “no.” If “yes” is selected, the Reporting System will automatically populate the fields in this section with the same contact information provided in the Cosmetic Firm Contact Person section above. If “no” is selected, please enter the Submitter’s information below.

• First Name:

Enter the submitter’s first name. • M.I.:

If applicable, enter the submitter’s middle initial. • Last Name:

Enter the submitter’s last name.



• Title: Enter the submitter’s full job title; for example, Regulatory Affairs Manager.

• Email Address:

Enter the submitter’s Email address. • Telephone Number:

Enter the submitter’s telephone number, include applicable country codes, area codes, and phone extension numbers.

• Fax Number:

Enter the submitter’s fax number, include applicable country codes and area codes. • Are you an employee of the [Cosmetic Firm]?

Select either “yes” or “no.” If “yes” is selected, you may proceed to the “Specify User Name and Password” section. If “no” is selected, you will be asked to select how you are affiliated with the Cosmetic Firm listed in the Cosmetic Firm section.

• Select your affiliation to the [Cosmetic Firm]: (check all that apply)

Select your relationship to the above cosmetic firm.

Submitter’s Firm Information If the Submitter is not the same as the Cosmetic Firm Contact person, enter the Submitter’s Firm information below. • Name of Firm:

Enter the full legal name of your Firm. • Other Names (DBA):

Enter any other name(s) your firm is doing business as. • Business Address Line 1:

Enter the number and street name of this firm. • Business Address Line 2:

If applicable, enter suite, floor, room number, etc. information. • City of Business:

Enter the full city name where this firm is located. • State/Province:

Enter the state or province where this firm is located. • Zip/Postal Code:

Enter the zip code or postal code where this firm is located. • Country:

Enter the country where this firm is located.



Specify User Name and Password You will now be self-assigning your own unique user name and password. The user name and password you select will be required to access/change any company or product information. It is your responsibility to retain your password in a safe location. • User Name:

Identify and enter a User Name for this Cosmetic Firm for which you are submitting cosmetic product information.

• Password: Identify and enter a password for this user account. Note: passwords must be at least eight (8) characters in length, consist of a combination of upper and lower case letters, and at least one number. Special characters (i.e., !, @, #, $, etc.) are encouraged, but not required.

• Re-type Password: For verification purposes, please re-enter your password.

By signing below, I am agreeing that I am an authorized representative of the firm, that the information I have provided on this form is complete and accurate, and includes a complete and accurate list of cosmetic products and chemicals that the firm is required to report under the California Safe Cosmetics Act (Health & Safety Code § 111791 et seq), violation of which is punishable as a misdemeanor, and violation with intent to defraud or mislead is punishable as a misdemeanor or a felony. I understand and agree that I will be bound by this ELECTRONIC signature as if it had been submitted in hard copy with my original signature. • Name of individual completing this form.

Enter your full name (first and last name of person completing this form). • Title:

Enter the title of the person completing this form; for example, Regulatory Affairs Manager. • Phone:

Enter the telephone number where we can reach you, include applicable country codes, area codes, and phone extension numbers.

• Electronic Signature:

Re-enter your name (first and last). By entering your full name again, this will serve as your official signature.

• Date:

This date field is automatically populated based on the server settings (Eastern Time Zone) and cannot be changed.

Note: It is your responsibility to keep up-to-date information with the CSCP. If your company information or status has changed, it is your responsibility to provide the updated information to the CSCP. For details on how to update your company profile, see section titled “Update Company Information.”



Annual Questions These Annual Questions are designed to help you determine whether you are required to report your cosmetic products to the California Department of Public Health. These screening questions will be displayed upon your first login of the year, and at the beginning of each calendar year thereafter. For more information on reporting requirements, refer to the section titled “Companies that are required to report.” • Did the [Cosmetic Firm] make $1 million or more in total aggregate sales from cosmetic

products both within and outside of California (including international) last year? This question applies to the cosmetic firm for which you are submitting information for. The $1 million threshold includes worldwide sales figures for the tax year. Select either “yes” or “no.”

• Do any of your cosmetic products sold in California contain at least one ingredient

required to be reported under California Health and Safety Code 111791-111793.5?

Select either “yes” or no.”

Home Page In order to submit product information to the CSCP, you must create an account via the California Safe Cosmetics Online Reporting System (https://safecosmetics.cdph.ca.gov/report). Once you have successfully logged into the online reporting system, this will be your Home Page. From the Home Page, you can add/update products and/or update your company information.

Login accounts are company-specific. If you are reporting for more than one company, please be sure that the name of the cosmetic firm for which you are submitting information is correct on the Home Page, this is especially important for consulting firms reporting on behalf of multiple companies. If this is not the company you wish to submit information for, click on the “Logout” link at the top, right hand corner of your screen to logout of the account, then enter the user name and password for the cosmetic firm for you wish to submit information. To submit your reportable product(s) or edit your previously reported products, click the “Add/update products” link. To edit your company profile, including your company contact information or any personnel changes, click the “Update company information” link.

https://safecosmetics.cdph.ca.gov/report




Note: for your protection, the online reporting system will automatically log you off when it is idle for more than 15 minutes. If your session has expired, your partial entry may or may not be saved. If your session has expired, you may access your partial entries by following these steps:

1. Close your web browser completely. 2. Re-launch your web browser and re-log in to your account. 3. Click the “Add/Update Products” link. 4. Locate the entry you were working on from your Previously Reported Products Table, and click

on the “Edit” button to access that submission. Click through the submission screens using the “Next” buttons at the bottom of each page, reviewing your partially-entered data and filling in any remaining fields.

5. Provide an electronic signature and click the “Submit” button on the final submission page to complete the online submission for this product.

Also note: all product entries, whether new or edited entries, must be finalized with an electronic signature in order to maintain compliance with the California Safe Cosmetics Act of 2005 (Health & Safety Code §111791-111793.5). When editing product entries, be sure to click through each submission page and provide an electronic signature to complete the product entry.

Reported Products Page By clicking on the “Add/update products” link from the Home page, you will arrive at the Previously Reported Products table. This table summarizes all products you have reported to the CSCP. Your table will be blank if you are accessing the system for the first time. If you have already reported products to the CSCP, your products will appear in this table. By default, this table is ordered by the unique CDPH Product ID number assigned to each product submission. You can change the sort order by click on the table headings for each column of data. To sort by Product Name, click on the “Product Name” heading as indicated in the figure below.

Note that this table contains both completed product entries as well as entries in draft mode. In order to be compliant with the Act, all entries must be finalized with an electronic signature. Draft product entries are highlighted in yellow for easy reference. To finalize draft entries, click on the “Edit” button in the corresponding row, click through the submission screens using the “Next” buttons at the bottom of each page, reviewing your partially-entered data for completeness and accuracy, then provide an electronic signature at the Signature page to complete the submission.

Add New Product To report a new product, click on the “Add New Product” button at the upper left hand corner of the Previously Reported Products table.



Product Page Unless otherwise indicated or selected as trade secret, all information provided could be available to the general public. For each field marked trade secret, the legal definition of trade secret must be met and you must mail supporting documentation to the California Department of Public Health. For more information on requesting confidentiality, please refer to the section titled “Trade Secrets.” Enter information for those products you are required to report exactly as they appear on the product label. • Name of Product:

Enter the name of the cosmetic product exactly as it appears on the label.

• Brand name: Enter the brand name of the cosmetic product exactly as it appears on the label.

• Company Product ID: (note: may be useful for future retrieval of submitted

information) Enter an identification number that your company uses to identify this product. This is not a required field, but may be helpful to you to retrieve previously submitted information for your products.

• Product ID (auto-generated by the California Department of Public Health) The online reporting system will automatically generate a product ID (also referred to as CDPH Product ID) for each product submission. The automated product ID number is for the California Department of Public Health internal use and cannot be changed. Please keep this Product ID number, as it is required to make any future changes to this product submission.

• Is this product currently being manufactured? Select “yes,” or “no”.

• If product is no longer manufactured, provide date this product was discontinued:

Enter the date this product was discontinued. Date must be entered in the MM/DD/YYYY format. If you don’t know when this product was discontinued, select “don’t know.”

• How is this [Cosmetic Firm] named on this product’s label? (check all that apply) Select how your company is listed on this product’s label.

• List all other firms named on the label and check how they are listed: (check all that

apply)



If another firm’s name also appears on the product label, enter this firm’s name and select their relationship to this product. If you are unable to determine a firm’s relationship to the product, select “Don’t Know.” Click “Add Firm…” to add a firm to the table. Repeat this step to enter other firms named on the label of this product. If no other firms are listed on the product label, continue to next question. If this firm is no longer named on the label of this cosmetic product, you may remove this firm by clicking the “Removed from Label” button next to the firm’s name and relationship to the cosmetic product. When removing a firm from this table, you will be prompted to enter the date this firm’s name was removed from the product label.

• Provide contact information for the Manufacturer you indicated above that is also listed on the product label (not including yourself): If the manufacturer is not named on the product label of this product, click on the “Add Manufacturer…” button. You will be directed to the Manufacturer – Firm Details Page where you will provide contact information for the manufacturer of this product. Repeat this step to enter additional manufacturers of this cosmetic product. If a manufacturer no longer manufactures this product, you can remove them by clicking the “Remove” button next to the manufacturer’s name. If the contact information for a manufacturer of this cosmetic product has changed, you can update the contact information by clicking the “Update Manufacturer Profile” button next to the manufacturer’s name. If there are no other manufacturers for this cosmetic product, click on the “Next” button at the bottom of the page to continue to the next question.

Manufacturer – Firm Details Page Provide contact information for this manufacturer (not including yourself). • Name of Manufacturer:

Enter the name of the firm that manufacturers this cosmetic product.

• Contact Name: Enter the name of the contact person of this manufacturer.

• Phone: Enter the phone number for this contact person of this manufacturer, include applicable country codes, area codes, and phone extension numbers.

• Address: Enter the location address of this manufacturer.

• Email: Enter the Email address of the contact person of this manufacturer.

To return to the Product Page, click on the “Continue” button at the bottom of the page.



Product Categories Page • Intended application area: (check all that apply)

Select all areas of the body where this cosmetic product may be applied. If the intended application area of your cosmetic product is not available in any of the available areas shown, select “Other” and describe where this cosmetic product may be applied.

• In what form is this product available?

Select the physical form in which this product is available. If your cosmetic product is not available in any of the available forms shown, select “other” and describe what form this cosmetic product is available. Note: For the purposes of reporting, each product form is considered a separate product. For example, for a product that is available as a spray and as a cream, even if these two forms have the same ingredients, they are considered two separate products for the purpose of reporting to the CSCP.

• Product Category: (check all that apply) Select the category that best describes the cosmetic product you are reporting. You may select more than one category if the product has more than one function. For example, if you are reporting a makeup foundation with sunscreen, you may select both “Foundations and Bases” and “Sunscreens.” General product categories are shown in bold. Click the (+) symbol to the left of each category to expand the selections for that category.

If none of the categories adequately describes the product, you may check “Other” but please note, there is no longer a space to add descriptive information. For more guidance on how to categorize your product, refer to Attachment 1: Cosmetic Product Categories. Note: A product whose intended use is both therapeutic (drug) and cosmetic, as defined by U.S. FDA, must be reported if that product meets the U.S. FDA’s definition of a cosmetic. Please refer to the section titled “Cosmetic products/ingredients that are not subject to the reporting provisions of the Act” of this set of instructions for more information.



Product Components Page Cosmetic manufacturers may purchase ingredients, such as fragrance, flavor, color, or other mixtures, from other sources to add to their own product formulas. Companies are required to report to CSCP all reportable ingredients in their products, including those contained in components obtained from secondary suppliers. A company that does not know the identity of ingredients or the composition of a product is not exempt from reporting. • Does your product contain a component (i.e., fragrance, color, etc.) supplied by another

company? Select “yes” or “no.” If your product does not contain a component supplied by another company, continue to the bottom of the page and click on the “Next” button.

• Do you know of all the ingredients in these components?

Select “yes” or “no.” If you do not know of all the ingredients in these components supplied by another company, you are required to inquire with the supplying company. If you know of all the ingredients in these components supplied by another company, you may proceed to report your reportable ingredients by clicking on the “Next” button on the bottom of the page.

• Document below, your attempt to obtain ingredient information from component

suppliers, including fragrance manufacturers. Select from the available choices for the outcome of your contact with the supplying companies.

Note: you are required by law to report any ingredients in your product that is a reportable chemical under the California Safe Cosmetics Act (CSCA) (Health and Safety Code § 111791-111793.5). Your company will be in violation of the CSCA if any of your cosmetic products contains a reportable chemical(s) and you do not report them to the California Department of Public Health. • Describe your contact with the supplying company:

a. Date of Inquiry: enter date you made the inquiry with the supplying company. Date must be entered in the MM/DD/YYYY format.

b. Name of Company: enter the name of the supplying company.

c. Address of Company: enter the full address of the supplying company.

d. Phone Number: enter the contact phone number for the supplying company, include applicable country codes, area codes, and phone extension numbers.

e. Date of response (if applicable): enter the date the supplying company responded to your inquiry. Date must be entered in the MM/DD/YYYY format.

f. Comments: enter any comments you would like to make regarding the supplying company and/or your inquiry with the supplying company.



Base Formulation Chemicals Page This page allows you to enter ingredients for a base formulation of this product, if applicable. This section only applies to the reportable ingredients in the base formulation. If the reportable ingredient is present only in a color, scent, or flavor additive (not in the base formula), please continue to the next section by clicking on the “Next” button at the bottom of your screen. DO NOT include ingredients here that are only in individual colors, scents, or flavors of this product. You will be prompted to do so when you specify colors, scents, or flavors later. DO NOT include ingredients that do not need to be reported, i.e. have not been identified as known or suspected carcinogens or reproductive or developmental toxicants according to Health and Safety Code § 111791-111793.5. To enter a reportable ingredient for this cosmetic product, click on the “Add Chemical” button. This will direct you to the Base Formulation Chemical Details page where you will provide further information about this reportable ingredient. Repeat this step to add additional ingredients as necessary.

If the product has been reformulated to remove the reported/reportable ingredient, click on the “Remove” button for the corresponding Chemical Name; you will be prompted to enter the date in which the reported/reportable chemical was removed from the base formulation. Once a chemical has been “removed,” a date will automatically populate next to the chemical name indicating it no longer contains the reported chemical.

To edit the information provided for this chemical, including trade secret declaration and chemical concentration, click the “Edit” button for the corresponding row. When you have provided all reportable ingredients for the base formulation of this product, click on the “Next” button at the bottom of your screen to proceed to the next section.



Base Formulation Chemical Details Page Please enter the chemical name or CAS number of the ingredient you wish to report, then hit the “Search” button. You may enter the complete chemical name or CAS number for ingredients you wish to report, or you may enter part of the chemical name or CAS number; the search feature will scan our database for any available matches. Once the search engine has returned any available matches based on your entry, select the correct ingredient from the list.

If you are not sure of or do not know the CAS number for a chemical, you should refer to the manufacturer or consult with your cosmetic chemist to determine which CAS number and/or chemical name to select. For general information on specific chemicals, including CAS numbers, chemical names and synonyms, you can refer to the National Institutes of Health’s PubChem database (https://pubchem.ncbi.nlm.nih.gov). If the chemical you wish to report is not available, email us at [email protected] for further instructions. Once you have made a selection, you will be prompted to provide detailed information for this ingredient in this product. Confirm that you have selected the correct chemical name and CAS number.

https://pubchem.ncbi.nlm.nih.gov/




If you have selected a different chemical and/or CAS number than the one you intend to report, click on the “Select different chemical” button to choose a different chemical.

If your product formulation meets the legal definitions of trade secret, you may declare an ingredient trade secret. Please carefully read the legal information that pops up when selecting trade secret. You must provide written documentation to support your trade secret claim to the CSCP within 30 days; otherwise, information marked as trade secret may be made available to the public. You may also select trade secret when reporting ingredient concentration. For more information on trade secret declarations, refer to the section of this document titled “Trade Secrets.”

• Would you like to declare this chemical ingredient a trade secret?If your product meets the legal definitions of trade secret, and you want to conceal the identity ofthe ingredients, you may select trade secret.

If “yes” is selected, the product will be displayed in the CSCP database as containing a reportableingredient, but the Chemical Name will be displayed as “Trade Secret.”

• Confirm that you would like to declare this chemical ingredient a trade secret:Please confirm whether you would like to declare this chemical ingredient a trade secret.

Reminder: If you declare this chemical ingredient a trade secret, supporting documentation needsto be mailed to the CSCP. For more information on trade secret declarations, please refer to thesection of this document titled “Trade Secrets.”

• What is the concentration of this chemical in the finished cosmetic product? If youentered a chemical concentration, also select the appropriate unit of measurement.Enter the chemical concentration in the box provided and select from the drop-down menu ofoptions, the appropriate unit of measurement for this chemical.

Note: at this time, the online reporting system can only take chemical concentrations in mg/g(milligrams per gram), mg/mL (milligrams per milliliter), µg/g (micrograms per gram), or µg/mL



(micrograms per milliliter) format. If your chemical concentration value is in format of percentage by weight, please make the appropriate conversions to one of the four available options.

• Would you like to declare this chemical concentration a trade secret? Select whether you would like to declare this chemical concentration a trade secret.

Click on the “Continue” button at the bottom of your screen to proceed to the next section.

Color-Scent-Flavor Combinations Page This page allows you to list all of the color [C], scent [S], flavor [F] (CSF) combinations for the reported product. List all CSF combinations of this product that share the same base formula you just reported. Color, scent, and flavor names should be typed as they appear to the consumer on the product label. As applicable, you may enter just a color, a scent, a flavor, or any combination of the three. To enter a color, scent, flavor, or any combinations of the three, enter the CSF name(s) in the appropriate text box(es) and click “Add C-S-F” to add that CSF combination into the CSF Table, as shown below. Repeat for all applicable CSF combinations. Once you have entered all applicable CSF combinations for this product, use the appropriate buttons in the table to:

1. Add or edit reportable chemical ingredient(s) specific to a particular CSF combination.

For more information on adding and/or editing a CSF chemical ingredient, see section below titled “CSF Chemicals Page.” Repeat for all applicable chemicals specific to this CSF combination.

2. List, where applicable, the kits and/or collection that contain this CSF combination

For more information on adding Kits & Collections to a CSF combination, see section below titled “CSF Kits & Collections Page.” Repeat for all applicable kits and collections specific to this CSF combination.



3. Indicate if a particular CSF combination has been discontinued

When you indicate the discontinuation of a CSF combination, you will be prompted to enter the date the CSF combination was discontinued. Date must be entered in MM/DD/YYYY format.

Kits & Collections For the purpose of reporting, a cosmetic kit is defined as a product containing various types of cosmetic products as one package. For example, a product which includes eye shadow, eye liner, blush and a compact mirror is considered a kit. Multiple colors, flavors or scents of any one type of cosmetic product are not considered a kit; for the purpose of reporting, these are considered collections. If the product indicated at the top of this webpage does not have a CSF combination, but is a part of a kit or collection, use the “Add/Edit” button below to list all relevant kits and/or collections.

When you have entered all applicable CSF combinations, click on the “Next: Receipt Preview” button at the bottom of your screen to proceed with your product submission.

Kits For the purpose of reporting, a cosmetic kit is defined as a product containing various types of cosmetic products sold in one package. For example, a product which includes eye shadow, eye liner, blush and a compact mirror is considered a kit.

1. List all kits that contain the Product shown at the top of this webpage. Kit names should be typed as they appear to the consumer on the product label.

Enter kit name, then click on the “Add Kit” button to add it to the Kits table. Repeat for all applicable kits.



2. Indicate if a previously reported kit has been discontinued.

Repeat for all applicable kits.

3. Indicate if a product previously reported in a Kitis no longer included in the Kit.

Repeat for all applicable kits.

Collections For the purpose of reporting, multiple shades of colors, scents, or flavors of any one type of cosmetic product is considered a collection. To report a collection for the product specified at the top of the page, follow the same instructions for entering kits above. Once you have entered all kits and/or collections for this specific Product/CSF combination, click on the “Return to CSF Combination” button to proceed.

CSF Chemicals Page This page allows you to review, add, edit or remove reportable chemical ingredients that are part of a specific CSF combination for the product shown at the top of this page. Note: Reportable ingredients present in all CSF combinations should be reported as part of the base formulation (see section of this document titled “Base Formulation Chemicals Page”). Before adding chemical(s) to any CSF combination, make sure you are adding the chemical to the correct CSF combination. If the product displayed in the top left corner of the webpage is not the one you intend to edit, click on the “Return to C-S-F Combinations” button at the bottom of the screen to return to the previous page and select the correct CSF combination. To add a chemical to each corresponding color, scent, or flavor, click on the “Add Chemical” button. You will be directed to the CSF Chemical Details Page (further explained in the “CSF Chemical Details Page” section below) where you will select the chemical you wish to add to this CSF combination.



From this page, you may also indicate that a chemical has been removed from this CSF combination by clicking the “Removed” button, or you may edit the previously submitted chemical details for this CSF combination by clicking the “Edit” button. If the product/CSF combination has been reformulated to remove the reportable ingredient, click on the “Remove” button to indicate this product no longer contains the reported chemical. Do not select “Remove” if the product has been discontinued. If the product is discontinued, please see section titled “Discontinued Products”. You will be prompted to enter a date the chemical was removed from the formulation; this date will be noted in our database and the public search site. All dates must be entered in MM/DD/YYYY format. Once you have entered all reportable ingredients for this product and CSF combination, click on the “Return to C-S-F Combinations” button to proceed with your product submission.

CSF Chemical Details Page Enter the chemical name or CAS number of the ingredient you wish to report, then hit the “Search” button. You may enter part of the chemical name or CAS number; the search feature will scan our database for any available matches. Once the search engine has returned any available matches based on your entry, select correct ingredient from the list of matches, as in the example below.



If you do not know the CAS number for a chemical, you should refer to the manufacturer or consult with your cosmetic chemist to determine which CAS number and/or chemical name to select. For general information on specific chemicals, including CAS numbers, chemical names and synonyms, you can refer to the National Institutes of Health’s TOXNET database (https://toxnet.nlm.nih.gov/). If the chemical you wish to report is not available, email us at [email protected] for further instructions. Once you have made a chemical selection, you will be prompted to provide detailed information for this chemical in this product. Confirm that you have selected the correct chemical name and CAS number.

If you have selected a different chemical and/or CAS number than the one you intend to report, click on the “Select different chemical” button to choose a different chemical. You may declare a chemical ingredient or the chemical concentration a trade secret. Note that you must provide written documentation to support your trade secret claim to the CSCP within 30 days to validate the trade secret declaration, otherwise, information marked as trade secret may be made available to the public. For more information on trade secret declarations, refer to the section of this document titled “Trade Secrets”.

https://toxnet.nlm.nih.gov/




• What is the concentration of this chemical in the finished cosmetic product? If you entered a chemical concentration, select the appropriate unit of measurement. Enter the chemical concentration in the box provided and select the appropriate unit of measurement from the drop-down menu of options. Note: at this time, the online reporting system can only take chemical concentrations in mg/g (milligrams per gram), mg/mL (milligrams per milliliter), µg/g (micrograms per gram), or µg/mL (micrograms per milliliter) format. If your chemical concentration value is in a format of percentage by weight, please make the appropriate conversions to one of the four available options.

Click on the “Continue” button at the bottom on your screen to proceed to the next section.

Product Submission Receipt Preview Page This screen offers a preview of your product submission receipt. IMPORTANT: YOUR SUBMISSION IS NOT COMPLETE UNTIL YOU HAVE COMPLETED THE ELECTRONIC SIGNATURE PAGE. Review the data you have entered for accuracy and completeness before proceeding to the Electronic Signature page. Pay particular attention to the CAS # and chemical name for all reported ingredients; these are difficult to change once the record has been submitted. Use the “Previous” button at the bottom of this page (and subsequent pages) to go back and correct any incorrect information. When you are satisfied with the information you have entered, proceed to the Electronic Signature page, fill out the required information, hit “Submit”, and then print or save an electronic copy of your final product submission receipt.

Electronic Signature Page • Comments:

Enter any comments you may have about this product submission. Note: these comments are not checked frequently. If you have an important message, please send an email to CSCP at [email protected].

By signing below, I am agreeing that I am an authorized representative of the firm, that the information I have provided on this form is complete and accurate, and includes a complete and accurate list of cosmetic products and chemicals that the firm is required to report under the California Safe Cosmetics Act (Health and Safety Code 111791 et seq), violation of which is punishable as a misdemeanor, and violation with intent to defraud or mislead is punishable as a misdemeanor or a felony. I understand and agree that I will be bound by this ELECTRONIC signature as if it had been submitted in hard copy with my original signature. • Name of individual completing this form

These fields are automatically populated based on the submitter’s information you have provided in your company profile. If this information is no longer true, please make the appropriate changes to your company profile (see section of this document titled “Update Company Information” for more information).

• Title • Phone




• Electronic Signature

Re-enter name of the individual completing this form (first, last). By entering your full name again, this serves as your official signature.

• Date:

This date field is automatically populated based on the server settings and cannot be changed.

A copy of this submission receipt will be sent to the designated Submitter in your company profile after you finalize the product submission with an electronic signature and the “Submit” button is activated. If you would like the receipt to go to someone else other than the designated Submitter, enter that person’s email address in the email field. You can also access submission receipts for this product (and others) from your Previously Reported Products table. See section of this document titled “Product Submission Receipts” on how to access your submission receipts.

Thanks!

Thank you for submitting your cosmetic information to the California Safe Cosmetics Program. The information you have entered is being transmitted to a secure California Department of Public Health (CDPH) server. Please retain a copy of your Product Submission Receipt for your records.

It is your responsibility to keep up-to-date cosmetic product information with CSCP.

If, after submission of this report, the product is discontinued or reformulated, you are responsible for updating the product information using the Edit feature of the online reporting system.

Changes to ingredients (with the exception of concentration and trade secret declaration) can only be made by submitting a Delete Request form. To request a Delete Request form, send an email to [email protected].

If a new product becomes reportable under the California Health and Safety Code §111791-111793.5, it is your responsibility to report that product to CSCP.

To report additional products, click on the “Return to Product List” button on the bottom of your screen. From the Product List, you can add a new product, edit an existing product entry, or access submission receipts for the products you have submitted. To edit your company profile information, click on the “Return to Home Page” button on the bottom of your screen, then click on the “Update company information” link.

Update Company Information It is your responsibility to keep your records up to date with CSCP. If your company information has changed, please update your company information promptly. To update your company information, click on the “Update company information” link from the Home Page to edit the Company Profile page. Provide your electronic signature at the bottom of the page to save your changes.






Attachment 1: Cosmetic Product Categories To answer the Product Categories question, please use this list to determine the appropriate Cosmetic Product Category. You may select more than one category if the product has more than one function. For example, if you are reporting a makeup foundation with Sun Protection Factor (SPF), you may select both “Foundations and Bases” and “Sunscreens.” Baby Products:

• Baby Shampoos • Baby Skin Care (includes lotions, oils, powders, creams, and other products intended for use on

a baby’s skin) • Baby Wash/Soap (includes solid, liquid, and gel cleansers) • Diaper Rash Treatment (includes all products including creams, ointments, and lotions intended

for the treatment or prevention of diaper rash) • Other Baby Products

Bath Products:

• Bath Additives (Includes bath oils, salts, soaks, and other similar products. Report hand washes under the category of Personal Care Products, and report Facial Cleansers under Skin Care Products)

• Body Washes and Soaps • Bubble and Foam Bath Products • Scrubs and Exfoliants • Other Bath Products

Fragrances:

• Cologne • Perfumes – Oils and Lotions • Perfumes – Solids and Powders • Perfumes/Eaux de Parfum (Includes liquid perfume products. Report sticks and powders under

Perfumes – Solids and Powders; Report oils and creams under Perfumes – Oils and Lotions.)

• Toilet Water/Eaux de Toilette (includes splashes, sprays, mists and other less concentrated products.)

• Other Fragrances Hair Care Product (non-coloring):

• Hair Conditioners (leave-in) • Hair Conditioners (rinse-out) • Hair Rinses (non-coloring) • Hair Shampoos (making a cosmetic claim) • Hair Shampoos with Anti-Dandruff properties • Hair Straighteners • Hair Styling Products (Includes hair spray, mousses, gels, pomades, tonics, dressings, and other

grooming aids. Report products that are used to color hair or which are used in the coloration process under Hair Coloring Products. Report products intended for use on eye lashes under Makeup Products.)

• Permanent Waves and Wave Sets • Other Hair Care Products



Hair Coloring Products:

• Hair Beaches • Hair Color Sprays (aerosol) • Hair Conditioners (leave-in) • Hair Conditioners (rinse-out) • Hair Dyes and Colors (includes oxidative or progressive hair coloring products) • Hair Lighteners with Color • Hair Shampoos (making a cosmetic claim) • Hair Tints and Rinses (coloring; includes semi-permanent and temporary products which over

time may wash off of hair) • Products Related to Hair Coloring (includes oxidants and developers that are used in the hair

coloring process) • Other Hair Coloring Products

Makeup Products (non-permanent):

• Blushes • Eye Shadow • Eyeliner/Eyebrow Pencils • Face Powders • Foundations and Bases (includes primers and concealers. Report highlighters under Face

Powders. • Skin bronzers • Lip Balm (making a cosmetic claim) • Lip Color – Lipsticks, Liners, and Pencils (includes all lip coloration products) • Lip Gloss/Shine (includes all products intended to add shine to lips) • Makeup Fixatives • Makeup Preparations • Mascara/Eyelash Products • Paints (e.g. facial, body) • Rouges • Other Makeup Product

Nail Products:

• Artificial Nails and Related Products (includes artificial nails, nail extenders, and the related glues and adhesives used)

• Basecoats and Undercoats • Cuticle Softeners • Nail Creams and Lotions • Nail Decoration (includes glitter and other decorative add-on products) • Nail Polish and Enamel (Includes pens and other alternative applicators of nail polish products.

Report UV Gel Nail Polishes under the specific category UV Gel Nail Polish.) • Nail Polish and Enamel Removers • UV Gel Nail Polish • Other Nail Products

Oral Hygiene Products:

• Mouthwashes and Breath Fresheners • Teeth Cleaning Product (includes toothpastes, gels, and other teeth cleaning products) • Teeth Whitening Products • Other Oral Hygiene Product



Personal Care Products:

• Antiperspirants (making a cosmetic claim) • Douches • Feminine Deodorants • Hand Cleansers and Sanitizers • Lubricants (e.g. personal, sexual, massage oil) • Underarm Deodorants • Other Personal Care Products

Shaving Products:

• Aftershave Products (includes lotions, talcum, and other products used after shaving) • Shaving Cream and other Beard Softeners (includes creams, gels, soaps, and other products

used to prepare the beard and face for shaving) • Other Shaving Products

Skin Care Products:

• Acne Products (making a cosmetic claim) • Anti-Wrinkle/Anti-Aging Products (making a cosmetic claim) • Depilatories • Facial Cream • Facial Masks • Foot Powders and Sprays • Nighttime Skin Cream • Powders (excluding aftershave, baby powder, and makeup face powder) • Skin Astringent (making a cosmetic claim) • Skin Bleaching (making a cosmetic claim) • Skin Cleansers • Skin Fresheners • Skin Moisturizers (making a cosmetic claim) • Skin Toner (making a cosmetic claim) • Sprays (excluding perfumes/fragrances) • Other Skin Care Products

Sun-Related Products:

• Indoor Tanning Products • Sunscreens (making a cosmetic claim) (includes all sunscreen claiming a Sun Protection Factor

[SPF]) • Suntan Enhancers (includes gels, creams, liquids, and powders applied to the body and face to

enhance or simulate a tan. • Other Sun-Related Products

Tattoos and Permanent Makeup

• Tattoos and Permanent Makeup



Attachment 2: Definitions Cosmetic

According to § 201 (i) of the Federal Food, Drug and Cosmetics Act (21 U.S. C § 321 (i)), cosmetic is defined as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”

Cosmetic Product

According to 21 Code of Federal Regulations (CFR) § 700.3 (b), a cosmetic product is defined as “a finished cosmetic, the manufacture of which has been completed. Any cosmetic product which is also a drug or device or component thereof is also subject to the requirements of Chapter V [drugs and devices] of the act.”

Cosmetic-Drug

U.S. FDA provides the following explanation of a cosmetic-drug (https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm#Both): “Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with U.S. FDA requirements for both cosmetics and drugs.”

Soap

U.S. FDA provides the following explanation of a cosmetic-drug (https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm#Both): “Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when – 1) The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and 2) the product is labeled, sold, and represented solely as soap [21 CFR 701.20].

Ingredient

According to 21 CFR § 700.3 (e), an ingredient is defined as “any single chemical entity or mixture used as a component in the manufacture of a cosmetic product.”

Incidental Ingredients

FDA regulation, 21 CFR § 701.3 (l), states that “The provisions of this section do not require the declaration of incidental ingredients that are present in a cosmetic at insignificant levels and that have no technical or functional effect in the cosmetic. For the purpose of this paragraph, incidental ingredients are:” • “Substances that are added to a cosmetic during the processing of such cosmetic but are

removed from the cosmetic in accordance with good manufacturing practices before it is packaged in its finished form.” [Example: Filter aid.]

• “Substances that are added to a cosmetic during processing for their technical or functional effect in the processing, are converted to substances the same as constituents of declared ingredients, and do not significantly increase the concentration of those constituents.” [Example: Sodium hydroxide added to a sodium stearate and stearic acid-containing cosmetic.]

https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm#Both

https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm#Both



• “Substances that are added to a cosmetic during the processing of such cosmetic for their technical and functional effect in the processing but are present in the finished cosmetic at insignificant levels and do not have any technical or functional effect in that cosmetic.” [Example: Defoaming agent.]

• “Substances that have no technical or functional effect in the cosmetic but are present by reason of having been incorporated into the cosmetic as an ingredient of another cosmetic ingredient.”

Note: The California Safe Cosmetics Program (CSCP) in the Department of Public Health (CDPH) developed this list of definitions primarily in response to questions stakeholders have raised about the California Safe Cosmetics Act of 2005 (“the Act”). It was developed with input from the CDPH Office of Legal Services. It is predominately a compilation of materials from either the Act or federal rules that are referenced in the Act. These CDPH determinations on what the law means have been taken either directly from the law itself, or is what CDPH has concluded embodies the only legal tenable interpretation of the Act. Thus, actions of CDPH in implementing the Act do not constitute formal rulemaking (see California Government Code Section 11340.9).



PART II: GENERAL INFORMATION ABOUT REPORTING

The California Safe Cosmetics Program Reporting System The California Safe Cosmetics Program (CSCP) in the California Department of Public Health (CDPH) developed an electronic reporting system for cosmetic manufacturers, distributors and/or packers to report cosmetic products to the CDPH as required by the California Safe Cosmetics Act of 2005 (“the Act”). This electronic reporting system, the California Safe Cosmetics Program Reporting System (referred to as the “online reporting system” or the “reporting app”) is currently only available online via the CSCP website (www.cdph.ca.gov/Cosmetics). The reporting system, guidelines, and instructions are only available in English. CDPH is unable to accept paper reports at this time. Company and product information must be submitted through the online reporting system (https://safecosmetics.cdph.ca.gov/report). Companies that cannot report online must contact CSCP at 1-877-325-3223.

Companies that are required to report Any company, whether domestic or foreign, that manufactures, distributes, and/or packages cosmetic products and meets the reporting requirements stated in California law is required to submit completed and signed electronic reporting forms to CSCP. A company is required to report if all of the following conditions are met:

• It has a total of at least $1 million or more in aggregate sales of cosmetic products both within and outside of California (including international), according to previous year tax records;

• It is the manufacturer, packer, and/or distributor named on the label of a product, which contains an ingredient known or suspected by an authoritative scientific body cited in the California Safe Cosmetics Act of 2005 (the Act) to cause cancer or reproductive harm;

• That product meets the U.S. Food and Drug Administration’s (U.S. FDA) definition of a cosmetic1; and

• That product was sold in California on or after January 1, 2007. A company that does not know the composition of a product is NOT exempt from reporting. It is responsible for obtaining and submitting required product information. For any given product, more than one company may be listed on the product label. All listed companies meeting the above definition are required to report. A joint report for a product may be submitted by a company, on behalf of other companies listed on the product label. The company filing must state that they are filing on behalf of the other companies. Reporting companies do not have to provide information on companies to whom they sell their products unless they are reporting on their behalf.

1 The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics (https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm#Definecosmetic) by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)].

http://www.cdph.ca.gov/Cosmetics


https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm#Definecosmetic



Companies that did not have a total of at least $1 million in aggregate sales of cosmetic products both within and outside of California according to previous year tax records are not required to report for that calendar year but have the option to report voluntarily if the product(s) meets the reporting requirements. Companies are to re-assess their eligibility to report on an annual basis.

Cosmetic products that must be reported Cosmetic product ingredients that contain any level (concentration) of a substance known or suspected to cause cancer or reproductive or developmental harm must be reported. The Act (California Health and Safety Code Section 111791-111793.5) provides specific criteria for determining which chemicals and products must be reported. To assist companies with reporting, CDPH compiled a list of reportable chemicals (https://www.cdph.ca.gov/ReportableIngredientsList) in consultation with the Office of Environmental Health Hazard Assessment (OEHHA). CDPH used lists and reports available from the authoritative scientific bodies cited in the Act. Note: this list of chemicals is available in English, Spanish, and Vietnamese. Cosmetic products sold in California on or after January 1, 2007, must be reported, even if the product is no longer manufactured, packaged, distributed, and/or reformulated to remove the reportable chemical ingredient since 2007. Upon reporting, you will be prompted to indicate the manufacturing status of the product and the date when the product is no longer manufactured, packaged, and/or distributed. If the product has been reformulated since January 1, 2007, please enter all reportable ingredients for the product prior to its reformulation. If the reportable ingredient is no longer present in the new formulation, indicate the date the ingredient was removed. A company that does not know the composition of a product is NOT exempt from reporting. It is responsible for obtaining and submitting required product information to the CSCP. This includes the composition of fragrances and flavoring ingredients and various mixtures from third party suppliers. Cosmetic products that contain any amount of a reportable chemical must be reported. Unless otherwise noted in the Reportable Ingredients List, cosmetic products that contain a reportable chemical must be reported regardless of whether the likely mode of exposure to the ingredient in that cosmetic product differs from the route of exposure identified by the authoritative scientific body as the pathway that is likely to lead to cancer or reproductive harm. A cosmetic product whose label states “may contain ingredient X” must be reported if a chemical in ingredient X is reportable. Trade secret information is not exempt from reporting to CDPH. However, CDPH cannot make any confidential and/or trade secret information available to the public unless the outcome of an official investigation deems the information is not confidential and/or trade secret. Companies that claim information as confidential/trade secret in the online reporting system must submit supporting written documentation to justify this designation. For more information on trade secrets and confidential data, see the section of this document titled “Trade Secrets”.

http://www.cdph.ca.gov/ReportableIngredientsList

http://www.cdph.ca.gov/ReportableIngredientsList



Cosmetic products/ingredients that are not subject to the reporting provisions of the Act Not all ingredients in a cosmetic product must be reported. Only ingredients known or suspected by an authoritative scientific body to cause cancer or reproductive or developmental harm must be reported. Cosmetic products without a reportable ingredient may not be accepted; you will not be able to proceed without entering at least one reportable chemical ingredient in either the base formula or the color, scent, or flavor combination. Incidental ingredients do not need to be reported. Incidental ingredients are defined by FDA regulations (21 CFR § 701.3 (1) as “the provisions of this section do not require the declaration of incidental ingredients that are present in a cosmetic at insignificant levels and that have no technical or functional effect in the cosmetic. For the purpose of this paragraph, incidental ingredients are:

• “Substances that are added to a cosmetic during the processing of such cosmetic but are removed from the cosmetic in accordance with good manufacturing practices before it is packaged in its finished form.” [Example: Filter aid.]

• “Substances that are added to a cosmetic during processing for their technical or functional effect in the processing, are converted to substances the same as constituents of declared ingredients, and do not significantly increase the concentration of those constituents.” [Example: Sodium hydroxide added to a sodium stearate and stearic acid-containing cosmetic.]

• “Substances that are added to a cosmetic during the processing of such cosmetic for their technical and functional effect in the processing but are present in the finished cosmetic at insignificant levels and do not have any technical or functional effect in that cosmetic.” [Example: Defoaming agent.]

• “Substances that have no technical or functional effect in the cosmetic but are present by reason of having been incorporated into the cosmetic as an ingredient of another cosmetic ingredient.”

If a chemical degrades into another chemical after application, the new chemical does not need to be reported. Only the chemicals identified in the products must be reported. Products that contain compounds of reportable chemicals do not need to be reported if the compounds themselves are not reportable. For example, if the reportable chemical is acrylamide, products that contain acrylamide must be reported but products that contain polymers of acrylamide would not need to be reported. If an authoritative scientific body cited in the Act lists the compound of a chemical as a known or likely carcinogen or reproductive toxicant, then products that contain polymers of that chemical must be reported. A product whose intended use is both therapeutic (drug) and cosmetic in nature, as defined by the U.S. Food and Drug Administration (U.S. FDA), must be reported if that product meets the Food and Drug Administration’s definition of a cosmetic (https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm#Definecosmetic). Note: Questions regarding whether certain products are considered to be cosmetics will be referred to the Food and Drug Branch in the California Department of Public Health. Soaps, in general, falls into a special regulatory category. Depending on its ingredients and intended use, soaps may be classified as a cosmetic, a drug, both or neither. Pursuant to the Act, soaps regulated by the U.S. FDA must be reported to the CDPH. For more information on soaps and its

https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm#Definecosmetic



regulations, please see U.S. FDA’s definition of a soap (https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm#Soap).

System security For security reasons, your account will be locked after three unsuccessful login attempts. When this happens, contact the CSCP at [email protected] to unlock your account and/or reset your password. For security reasons, the online reporting system will automatically log you out of the system if it is idle for more than 15 minutes. Hitting the “Next” buttons at the bottom of each page saves the data on that page, so you should only have lost information on the screen you were viewing when you were timed out. The online reporting system has met all CDPH security standards for information technology and online reporting systems. However, for yours and your company’s protection, please do not share your password with others. To further protect the security of the reported information, the CDPH might do one or more of the following:

• Contact a reporting company to verify users;

• Contact a reporting company to verify data entries;

• Contact a reporting company if suspicious activity is observed or reported;

• Audit submitted data for possible fraudulent entries.

Deadline for submitting information to the California Department of Public Health The initial reporting phase began June 15, 2009. Companies had four (4) months after this date, or until October 15, 2009, to submit their product information for that phase. After October 15, 2009, reporting will be on a continuous basis. When a product becomes reportable after this date, companies will be given one month (30 days) to report the product. Companies can submit changes to previously submitted information, including product reformulations and/or discontinue reported products, at any time after reporting.

Trade Secrets Trade secret information is not exempt from reporting to the CDPH. Information disclosed in the online reporting system will be available to the public unless:

1. The person submitting it:

• Requests exemption from public disclosure by selecting the Trade Secret option in the appropriate field, and

• Provides the proper written supportive documentation demonstrating that the information is a trade secret, or is commercial or financial information that is privileged or confidential, and

https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm#Soap




2. The CDPH accepts the information in confidence upon review of the submitted factual data.

Companies will have the opportunity to mark ingredients and concentration as trade secret. For purposes of the Safe Cosmetics Act, trade secret designation is determined “pursuant to the procedures established in Part 20 and Section 720.8 of Part 720 of Title 21 of the Code of Federal Regulations” (California Health and Safety Code § 111791). The California Safe Cosmetics Program requires documentation from the US FDA granting trade secret status, indicating that the information so designated is indeed trade secret under federal law. The ingredient(s) must also meet the definition of “trade secret” under the California law. Under the California Uniform Trade Secrets Act, “trade secret” is defined as information, including a formula, that (1) derives independent economic value from not being generally known to the public or to other persons who can obtain economic value from its disclosure or use; and (2) is the subject of efforts that are reasonable under the circumstances to maintain its secrecy. Note that ingredients listed on the labels of products sold to the public are “known to the public” and therefore do not meet the definition of a trade secret. For each chemical ingredient a company is seeking to designate a trade secret, companies must submit the same type of information that other CDPH programs require with regard to claims of confidentiality, including but not limited to:

1. Provide written documentation from the US FDA granting the ingredient trade secret status and

2. Provide proof that the ingredient(s) meets the Uniform Trade Secrets Act’s (California Civil Code § 3426.1) definition of “trade secret.”

Documentation must be submitted for each ingredient you are seeking to designate a trade secret. The CDPH cannot make confidential and/or trade secret information available to the public unless the outcome of an official investigation deems the information is not confidential and/or trade secret. Failure to submit the above documentation will result in the removal of the trade secret designation and the ingredient identity may be released on the CSCP public searchable database.

Product Submission Receipts A Product Submission Receipt is generated for each CDPH Product ID submitted under the California Safe Cosmetics Act (“the Act”). Users are able to view, save and print a product submission receipt for each individual product entry. This applies to previously reported products and all new product submissions. This receipt reflects the most recent version of the data submitted for each product.

Adobe Acrobat Reader is required to view your Product Submission Receipt. If you do not have Adobe Acrobat Reader installed, you may download it through Adobe’s website (http://get.adobe.com/reader/).

Product receipts may be accessed in two different ways:

http://get.adobe.com/reader/



1. From the Previously Reported Products table, click on the “Receipt” button to the far right of each product entry.

2. Obtain receipt at the end of each product entry. This final receipt includes your electronic

signature. You can save or print this document for your records. A preview of your Product Submission Receipt will appear on the screen prior to the Electronic Signature page. This preview allows you to review your product submission for accuracy and completeness before it is submitted into our database. To correct any incorrect information, use the “Previous” button at the bottom of each page to navigate through the submission pages to make the necessary corrections; do not use your web browser’s back/forward buttons.

We recommend that you review your existing product submissions for accuracy and completeness. Many fields may be edited using the “Edit” button, however, delete requests (including ingredient deletes) must be made in writing to CSCP. You can obtain a Submission Delete Request Form by emailing [email protected].

Note that submission receipts are for an individual product, and not a list of all reported products. If you would like a list of all of your reported products, contact CSCP at [email protected].

Delete Requests Many data fields can be edited to correct erroneously entered information while others are not (i.e., chemical identification; Colors, Scents, Flavors). If you have reported an ingredient that should not have been reported (incidental ingredients, selected wrong chemical name, reported the same chemical more than once for a single entry), you may petition the removal of the incorrect submission by submitting a Submission Delete Request Form. Contact CSCP at [email protected] for more information.

Note that discontinued products and product reformulations (removed ingredients) are not removed from the database, but are indicated as discontinued or removed in the public search site.

Discontinued Products If your product is no longer manufactured, you will need to update its manufacturing status by editing the product entry and selecting its current manufacturing status; you will be prompted to enter a date the product was discontinued.

Products sold on or after January 1, 2007 are not exempt from reporting even if they have since been discontinued or no longer sold in California or to a California resident.

Discontinued products are flagged in the online searchable database with the date you specify as its discontinued date.

Product Reformulations If the product has been reformulated and the reported ingredient removed during this process, you will need to edit the product entry to indicate a removal of a reported ingredient. You will be prompted to enter the date the ingredient was removed.






Products sold on or after January 1, 2007 are required to be reported even if the reportable ingredient was removed in the reformulation. If the reportable ingredient is no longer present in the new formulation, indicate the date the ingredient was removed where applicable.

When reported ingredients are removed as a result of a reformulation, those ingredients are flagged in the online searchable database with the specified date the ingredient was removed.

Availability of company/product information All information submitted to the CDPH through the online reporting system will remain on file on a secure server with limited access by designated staff only. Confidential and trade secret information is not subject to the Public Records Act. Non-confidential product information will be available to the public in a searchable database (https://safecosmetics.cdph.ca.gov/search) based on data reported by companies. This product information will be updated as new information is received through the online reporting system.

https://safecosmetics.cdph.ca.gov/search

Documents

PART I: ITEM-BY-ITEM INSTRUCTIONS FOR THE ONLINE … Document Library...California Safe Cosmetics Program – California Department of Public Health Page 1 of 38 . Instructions for